Hexanedioic acid, 1,6-bis(2-propylheptyl) ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japan MAFF 8147

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

XPB 115

IUPAC Name:

XPB 115

Constituent 2

Reference substance name:

Hexanedioic acid, bis(2-propylheptyl) ester

IUPAC Name:

Hexanedioic acid, bis(2-propylheptyl) ester

Constituent 3

Reference substance name:

1,6-bis(2-propylheptyl) hexanedioate

EC Number:

940-510-9

Cas Number:

103043-58-9

Molecular formula:

C26 H50 O4

IUPAC Name:

1,6-bis(2-propylheptyl) hexanedioate

Test material form:

other: liquid

Details on test material:

please refer to the confidential details of the test material

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight) 170-181 g ( on day 0)
- Fasting period before study:Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Makrolon cage, type III, single housing
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 – 70%
- Air changes: approx. 10 per hour
- Photoperiod: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

IN-LIFE DATES: 2014-06-24 to 2014-07-09

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw/d (5.49 ml/kg bw undiluted substance)

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weight determination:
Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations:
Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
Mortality:
A check for any dead or moribund animals was made at least once each workday
- Necropsy of survivors performed: yes
Necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2- inhalation in a chamber with increasing concentrations over time.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

No mortality occurred

Clinical signs:

other: Impaired general state and piloerection at hour 2 and 3 and on day 9 after administration was observed in one animal.

Gross pathology:

There were no macroscopic pathological findings.